NCT07471230尚未招募2 期
Phase II Randomized Controlled Trial Evaluating Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism
Biocells Medical1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年11月23日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- NMSS
研究概览
简要总结
This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.
The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 48 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months
排除标准
- •Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression
研究组 & 干预措施
Neuroinduced Mesenchymal Stem Cells
Experimental
200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.
干预措施: Intrathecal (IT) (Biological)
Mesenchymal Stem Cell Derived Exosomes
Experimental
1×10¹¹ particles per infusion
干预措施: Intravenous (Biological)
Intravenous saline infusion
Placebo Comparator
干预措施: Intravenous (Biological)
结局指标
主要结局
NMSS
时间窗: 48
Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least
次要结局
- MDS-UPDRS(48)
研究者
研究点 (1)
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